Identity
- Trade Name
- Medisana FDA UDI
- Generic Name
- Hand-held electric massager FDA UDI
- Device Name
- Electronically powered device with a vibrating mode to treat the neck muscles. Optionally with heating function by red light. It is typically used for physiotherapie e.g reduce muscular tensions for domestic use. FDA UDI
- Model / Reference
- NM 10L FDA UDI
- Description
- Electronically powered device with a vibrating mode to treat the neck muscles. Optionally with heating function by red light. It is typically used for physiotherapie e.g reduce muscular tensions for domestic use. FDA UDI
Identifiers
- Catalog Number
- 99538 FDA UDI
- Primary DI / UDI-DI
- 04015588995385 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Hand-held electric massager FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand-held electric massager
Medisana by Medisana GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held electric massager.
- Massage Gun — ShenZhen Pentasmart Technology Co, .Ltd · Class I
- G5® — GENERAL PHYSIOTHERAPY INC · Class I
- D-ACTOR® — Storz Medical AG · Class I
- RENPHO Eye Massager — JOICOM CORPORATION · Class I
- Maptag — Sanwei Taige (Suzhou) Medical Co., Ltd. · Class I
- Homedics — Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd. · Class I
- PM-750 — PRO MEDICAL SUPPLIES, INC. · Class I
- Homedics — ZHANGZHOU EASEPAL INNOVATION CO., LTD. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medisana GmbH
Sources (1)
- FDA UDI 247462bd-7c97-43c3-b202-c47fd0ad645b 35 fields · synced May 30, 2026